MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for MEDIVATOR VERISCAN LEAK TESTER VERISCAN LT VER-LT manufactured by Medivators Inc..
[176020017]
There have been two recent incidents of endoscopes that passed automated leak testing, quality checks, and appropriate high-level disinfection that were found to have residual fluid. These scopes were found to have leaks when inspected by the mfr. Flexible scopes found to pass automated veriscan leak test but failed when manually checked and contained leaks when inspected by oem. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092340 |
| MDR Report Key | 9601618 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-15 |
| Date Added to Maude | 2020-01-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIVATOR VERISCAN LEAK TESTER |
| Generic Name | BULB, INFLATION, FOR ENDOSCOPE |
| Product Code | FCY |
| Date Received | 2020-01-16 |
| Returned To Mfg | 2020-01-14 |
| Model Number | VERISCAN LT |
| Catalog Number | VER-LT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | MN US |
| Brand Name | MEDIVATOR VERISCAN LEAK TESTER |
| Generic Name | BULB, INFLATION, FOR ENDOSCOPE |
| Product Code | FCY |
| Date Received | 2020-01-16 |
| Model Number | VERISCAN LT |
| Catalog Number | VER-LT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |